[Hiring] Scientific Documentation Specialist @Ignite HR Solutions and our Clients

Role Description

The Scientific Documentation Specialist provides cross-functional scientific documentation support to help ensure the accuracy, completeness, consistency, traceability, and accessibility of Alterity's scientific and regulated documentation. The role combines scientific document quality control and source verification with document and information management activities. Based within Regulatory Affairs and Quality Assurance, the role works across Clinical, Nonclinical and Chemistry, Manufacturing and Controls (CMC) to organize and maintain documentation, verify information against designated source materials, and support regulatory submissions, audits, inspections and due diligence. Priorities will be agreed with the line manager in consultation with functional leads. The breadth and focus of responsibilities will evolve based on program priorities, organizational needs, and demonstrated capabilities. Position reports to VP, Regulatory Affairs and Quality Assurance.

Key Responsibilities

• Scientific Documentation and Quality Control
  • Perform documented QC of clinical, nonclinical, CMC and regulatory documents using established procedures and checklists.
  • Verify numerical values, units, tables, figures, references and factual statements against designated source reports, datasets, approved outputs or supporting records.
  • Review related documents for consistency of study information, terminology, data, document identifiers and scientific content.
  • Check formatting, numbering, terminology, cross-references, references and document versions.
  • Record discrepancies and queries, coordinate resolution with authors and subject-matter experts, and track corrections to closure.
  • Support source verification of information incorporated into regulatory submission documents and other key development records.
• Document Management and Systems
  • Organize, classify and maintain scientific, regulatory and quality documentation in SharePoint, Veeva and other designated document repositories.
  • Coordinate implementation and improvement of document filing structures, naming conventions, metadata and workflows with Regulatory/QA, functional leads, IT and system providers.
  • Support document-management and filing-system implementation activities, including requirements gathering, document organization, migration, reconciliation and user guidance.
  • Coordinate receipt and migration of records from CROs, manufacturers, consultants and legacy repositories.
  • Reconcile document inventories and verify completeness, appropriate classification and successful transfer.
  • Maintain document registers and trackers and identify missing, duplicate, superseded or incorrectly filed records for resolution with document owners.
  • Support appropriate version control, review, approval, retrieval and archiving practices.
• Cross-Functional Coordination and Readiness
  • Work with Regulatory Affairs, Quality Assurance, Clinical, Nonclinical and CMC teams to support documentation needs and agreed program priorities.
  • Coordinate document review and approval cycles and follow up on outstanding inputs and deliverables.
  • Prepare and retrieve document packages for regulatory submissions, audits, inspections and due diligence, maintaining traceability to approved source records.
  • Maintain practical QC checklists, filing guides, templates and work instructions.
  • Support user onboarding and consistent document-management practices.
  • Identify opportunities to improve document quality, traceability, accessibility and efficiency.

Qualifications

• Bachelor's degree in life sciences, biomedical sciences, chemistry, pharmacology or a related scientific discipline.
• Demonstrated experience working accurately with scientific reports, technical documents or research data through industry, research, internships or substantial academic work.
• Ability to understand scientific terminology and concepts and to compare information across multiple sources.
• Ability to identify inconsistencies, discrepancies and potential errors and recognize when review by a functional subject-matter expert is required.
• Understanding of document control, version management, confidentiality and accurate recordkeeping.
• Strong written communication, organization, analytical ability and attention to detail.
• Ability to manage multiple priorities and work effectively across functions.

Requirements

• One to three years of relevant experience in biotechnology, pharmaceuticals, a CRO or another regulated scientific environment.
• Experience with scientific document QC, regulatory documentation, controlled records, document management or document migration.
• Familiarity with clinical, nonclinical, CMC or regulatory submissions.
• Working knowledge of GCP, GLP and/or GMP and associated documentation and data-integrity principles.

Technical / Software Knowledge

• Microsoft Word, Excel, PowerPoint
• Adobe Acrobat
• SharePoint
• Veeva Vault or equivalent electronic document management systems
• Egnyte
• Smartsheet
• R - asset
• SAS - asset

Working Relationships and Accountability

The Scientific Documentation Specialist works closely with Regulatory Affairs, Quality Assurance, Clinical, Nonclinical, CMC, medical writers and external service providers. The role performs scientific document QC, source verification and document-management activities within an agreed scope and with appropriate training and subject-matter support. Scientific interpretation, technical decisions and final content approval remain the responsibility of the appropriate functional experts. System ownership, access administration, configuration and validation remain with designated system owners; the Scientific Documentation Specialist supports and coordinates document organization, implementation and operational activities.

Expected Outcomes

• Scientific and regulated documents are consistently organized, readily retrievable and identifiable by current status and version.
• Data, references and factual information are appropriately verified against designated source materials.
• QC findings and source discrepancies are documented, traceable and resolved before document finalization.
• Cross-functional teams receive reliable scientific documentation support within agreed timelines.
• Document repositories and filing practices support regulatory, quality, development and business-readiness needs.

Location

Remote- US-based candidates

Pay Range

$45.00-50.00 per hour.

Benefits

• Medical, dental, and vision insurance